Trial Outcomes & Findings for Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction (NCT NCT00891878)
NCT ID: NCT00891878
Last Updated: 2018-07-24
Results Overview
The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves. All patients meeting the eligibility criteria, who started treatment will be considered evaluable for the primary endpoint. If a patient is still alive 3 years after registration, no further follow-up is required. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
COMPLETED
PHASE2
12 participants
Up to 3 years
2018-07-24
Participant Flow
Participant milestones
| Measure |
Arm A (Capecitabine)
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
|
Arm B (Capecitabine+Sunitinib)
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction
Baseline characteristics by cohort
| Measure |
Arm A (Capecitabine)
n=6 Participants
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
|
Arm B (Capecitabine+Sunitinib)
n=6 Participants
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.5 years
n=5 Participants
|
73 years
n=7 Participants
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: All evaluable patients
The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves. All patients meeting the eligibility criteria, who started treatment will be considered evaluable for the primary endpoint. If a patient is still alive 3 years after registration, no further follow-up is required. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Arm A (Capecitabine)
n=6 Participants
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
|
Arm B (Capecitabine+Sunitinib Malate)
n=6 Participants
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
|
|---|---|---|
|
Comparison of Progression-free Survival
|
6.1 Months
Interval 0.6 to 9.2
|
2.4 Months
Interval 0.6 to 8.4
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All evaluable patients
A confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations ≥4 weeks apart. Confirmed tumor response will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rates between the 2 arms will be compared using a Chi-Square or Fisher's Exact test. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Arm A (Capecitabine)
n=6 Participants
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
|
Arm B (Capecitabine+Sunitinib Malate)
n=6 Participants
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
|
|---|---|---|
|
Response Rate (Complete Response or Partial Response)
|
0 percentage of patients
Interval 0.0 to 46.0
|
33 percentage of patients
Interval 4.0 to 78.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All evaluable patients
Overall survival is defined as the time from randomization to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A (Capecitabine)
n=6 Participants
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
|
Arm B (Capecitabine+Sunitinib Malate)
n=6 Participants
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
|
|---|---|---|
|
Overall Survival
|
6.2 Months
Interval 1.5 to 18.8
|
5.9 Months
Interval 0.9 to 29.8
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All evaluable patients
Time to disease progression is defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A (Capecitabine)
n=6 Participants
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
|
Arm B (Capecitabine+Sunitinib Malate)
n=6 Participants
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
|
|---|---|---|
|
Time to Disease Progression
|
7.56 months
Interval 1.58 to 9.2
|
2.46 months
Interval 2.33 to 8.44
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All evaluable patients
Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.
Outcome measures
| Measure |
Arm A (Capecitabine)
n=6 Participants
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
|
Arm B (Capecitabine+Sunitinib Malate)
n=6 Participants
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
|
|---|---|---|
|
Time to Treatment Failure
|
1.63 months
Interval 1.51 to 10.74
|
2.53 months
Interval 0.69 to 8.48
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients who achieved an objective response to be either a CR or PR were included in this analysis.
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.
Outcome measures
| Measure |
Arm A (Capecitabine)
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
|
Arm B (Capecitabine+Sunitinib Malate)
n=2 Participants
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
|
|---|---|---|
|
Duration of Response
|
—
|
4.75 months
Interval 3.06 to 6.44
|
Adverse Events
Arm A (Capecitabine)
Arm B (Capecitabine+Sunitinib Malate)
Serious adverse events
| Measure |
Arm A (Capecitabine)
n=6 participants at risk
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
|
Arm B (Capecitabine+Sunitinib Malate)
n=6 participants at risk
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
Thrombosis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
Other adverse events
| Measure |
Arm A (Capecitabine)
n=6 participants at risk
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
|
Arm B (Capecitabine+Sunitinib Malate)
n=6 participants at risk
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
100.0%
6/6 • Number of events 29
|
100.0%
6/6 • Number of events 20
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
4/6 • Number of events 10
|
33.3%
2/6 • Number of events 6
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
33.3%
2/6 • Number of events 2
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
2/6 • Number of events 4
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
100.0%
6/6 • Number of events 11
|
66.7%
4/6 • Number of events 10
|
|
Gastrointestinal disorders
Salivary gland disorder
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 5
|
50.0%
3/6 • Number of events 3
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 9
|
50.0%
3/6 • Number of events 4
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
2/6 • Number of events 9
|
33.3%
2/6 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Investigations
INR increased
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
50.0%
3/6 • Number of events 9
|
50.0%
3/6 • Number of events 10
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Number of events 5
|
50.0%
3/6 • Number of events 11
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1
|
50.0%
3/6 • Number of events 11
|
|
Investigations
Weight loss
|
0.00%
0/6
|
16.7%
1/6 • Number of events 8
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • Number of events 3
|
16.7%
1/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
50.0%
3/6 • Number of events 8
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
33.3%
2/6 • Number of events 8
|
50.0%
3/6 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
3/6 • Number of events 4
|
33.3%
2/6 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
4/6 • Number of events 8
|
33.3%
2/6 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
3/6 • Number of events 8
|
33.3%
2/6 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
50.0%
3/6 • Number of events 9
|
66.7%
4/6 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
50.0%
3/6 • Number of events 4
|
33.3%
2/6 • Number of events 4
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place